Krajina: Singapur
Jazyk: angličtina
Zdroj: HSA (Health Sciences Authority)
Empagliflozin; Linagliptin
BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
A10BD19
TABLET, FILM COATED
Empagliflozin 10.00 mg; Linagliptin 5.00 mg
ORAL
Prescription Only
Boehringer Ingelheim Pharma GmbH & Co. KG
ACTIVE
2017-06-16
1 Abcd Glyxambi ® 1. NAME OF THE MEDICINAL PRODUCT Glyxambi Film-Coated Tablets 10mg/5mg Glyxambi Film-Coated Tablets 25mg/5mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg or 25mg empagliflozin and 5mg linagliptin For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Glyxambi 10mg/5mg: Pale yellow, arc triangular, flat-faced, bevel-edged, film-coated tablets. One side is debossed with the Boehringer Ingelheim company symbol, the other side is debossed with "10/5". Glyxambi 25mg/5mg: Pale pink, arc triangular, flat-faced, bevel-edged, film-coated tablets. One side is debossed with the Boehringer Ingelheim company symbol, the other side is debossed with "25/5". 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS GLYXAMBI tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate. (See Clinical Trials) _ _ _ _ LIMITATIONS OF USE GLYXAMBI is not recommended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. GLYXAMBI has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using GLYXAMBI. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Recommended Dosage The recommended dose of GLYXAMBI is 10 mg empagliflozin/5 mg linagliptin once daily in the morning, taken with or without food. In patients tolerating GLYXAMBI, the dose may be increased to 25 mg empagliflozin/5 mg linagliptin once daily. In patients with volume depletion, correcting this condition prior to initiation of GLYXAMBI is recommended. No studies have been performed specifically examining the safety and efficacy of GLYXAMBI in patients previously treated with other oral antihyperglycemic agents and switched to GLYXAMBI. Any 2 change in therapy of type 2 diabetes should be undertaken with care and approp Prečítajte si celý dokument